The FDA Enforcement Report for the Week of November 7 lists the ongoing Class II recall of the ARIA radiation oncology product from Varian Medical Systems, Palo Alto, Calif.
Varian Medical Systems Inc Oncology Systems identified an anomaly with the ARIA oncology information system version 11 where monitor units of one fraction may be incorrect when partial treatment is being continued.
Initiated September 9, 2012, the recall involves 205 systems distributed worldwide and across the US.
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